Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Not for acute use
There are no clinical data to support the use of Trelegy Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Trelegy Ellipta should not be used to treat acute asthma symptoms.

Deterioration of disease

Increasing use of short-acting bronchodilators to relieve symptoms may indicate deterioration of disease control. In the event of deterioration of asthma or COPD during treatment with Trelegy Ellipta, a re- evaluation of the patient and of the asthma or COPD treatment regimen should be undertaken.

Patients should not stop therapy with Trelegy Ellipta, in asthma or COPD, without physician supervision since symptoms may recur after discontinuation.

Asthma-related adverse events and exacerbations may occur during treatment with Trelegy Ellipta. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of Trelegy Ellipta.

Paradoxical bronchospasm

Administration of fluticasone furoate/umeclidinium/vilanterol may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening. If paradoxical bronchospasm occurs, treatment should be discontinued immediately. The patient should be assessed and alternative therapy instituted if necessary.

Cardiovascular effects

Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively (see section 4.8). Therefore, Trelegy Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.

Patients with hepatic impairment


For patients with moderate to severe hepatic impairment receiving Trelegy Ellipta, the 92/55/22 micrograms dose should be used, and patients should be monitored for systemic corticosteroid-related adverse reactions (see section 4.2 Posology and method of administration and section 5.2 Pharmacokinetic properties).

Systemic corticosteroid effects

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Coexisting conditions

Trelegy Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.

Trelegy Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.

Anticholinergic activity

Trelegy Ellipta should be used with caution in patients with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Trelegy Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.

Caution should be advised when prescribing Trelegy Ellipta in patients with urinary retention or risk factors for urinary retention, e.g. benign prostatic hypertrophy. Cases of acute urinary retention have been observed in the post-marketing setting (see section 4.8).


Pneumonia in patients with COPD
An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.

There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.

Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.

Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.

Pneumonia in patients with asthma

An increased incidence of pneumonia in patients with asthma receiving higher doses of Trelegy Ellipta cannot be excluded. This is based on clinical experience with fluticasone furoate/vilanterol, where there was 
a trend toward an increased risk of pneumonia for fluticasone furoate/vilanterol 184/22 micrograms compared with fluticasone furoate/vilanterol 92/22 micrograms and placebo.

Hypokalaemia

Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

No clinically relevant effects of hypokalaemia were observed in clinical studies with Trelegy Ellipta at the recommended therapeutic dose. Caution should be exercised when Trelegy Ellipta is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).

Hyperglycaemia

Beta2-adrenergic agonists may produce transient hyperglycaemia in some patients. No clinically relevant effects on plasma glucose were observed in clinical studies with fluticasone furoate/umeclidinium/vilanterol at the recommended therapeutic dose. There have been reports of increases in blood glucose levels in diabetic patients treated with fluticasone furoate/umeclidinium/vilanterol and this should be considered when prescribing to patients with a history of diabetes mellitus (see section 4.8). Upon initiation of treatment with Trelegy Ellipta, plasma glucose should be monitored more closely in diabetic patients.

Excipients

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.

Effects on Driving

4.7   Effects on ability to drive and use machines
Fluticasone furoate/umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.